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The Health Service Products (Provision and Disclosure of Information) Regulations 2018

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Information to be recorded and kept about supply of health service medicines other than imported special health service medicines: other UK producers

This section has no associated Explanatory Memorandum

18.—(1) A UK producer must—

(a)record the information mentioned in paragraph (2) for—

(i)each supply by the producer of a presentation of relevant health service medicine which the producer has manufactured, and

(ii)each supply by the producer (otherwise than as a medicines wholesaler) of any presentation of relevant health service medicine, and

(b)keep that information for a period of four years beginning with the day on which it is recorded.

(2) The information is—

(a)the name of the person to whom the presentation is supplied (“the purchaser”),

(b)if known to the producer, whether the purchaser is in Category A, B, C or D,

(c)the quantity, by pack size, supplied to the purchaser,

(d)the net sales income, or a reasonable estimate of the net sales income, for the supply of the presentation to the purchaser,

(e)the terms on which any discounts, payments, or payments or benefits in kind taken into account when calculating the net sales income were given by the producer,

(f)the name of the person to whom those discounts were given, if that person is not the purchaser,

(g)if known to the producer, whether the presentation is an English health service product, a Welsh health service product, a Scottish health service product or a Northern Ireland health service product, and

(h)if it is a presentation of made special health service medicine, the excipient formulations supplied (if any).

(3) In this regulation, “relevant health service medicine” means a health service medicine other than an imported special health service medicine.

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